The Common Technical Document (CTD) is the harmonised format used by ICH regions and most aligned national authorities for pharmaceutical registration dossiers. Here is a module-by-module practical guide for generic Deferasirox.
Module 1 - Administrative & Prescribing Information #
Country-specific. Includes application form, cover letter, product information (SmPC / PIL / carton), proof of payment, debarment declarations, legalised / apostilled documents.
Module 2 - Summaries #
- 2.3 Quality Overall Summary (QOS)
- 2.4 Non-Clinical Overview (literature-based acceptable for known API)
- 2.5 Clinical Overview
- 2.6 Non-Clinical Written and Tabulated Summaries
- 2.7 Clinical Summary (incl. bioequivalence)
Module 3 - Quality #
| Section | Content |
|---|---|
| 3.2.S - Drug Substance (API) | Manufacturer, manufacturing process, specification, characterisation, stability |
| 3.2.P - Drug Product | Description, composition, formulation development, manufacturing process, excipient controls, specification, stability |
| 3.2.P.7 | Container closure system |
| 3.2.P.8 | Stability data (ICH Q1A) |
Module 4 - Non-Clinical Study Reports #
For generic Deferasirox, typically literature-based; no new non-clinical studies required in most jurisdictions.
Module 5 - Clinical Study Reports #
- 5.3.1 Bioequivalence study vs reference product
- 5.4 Literature references / published clinical studies
Format Considerations #
- eCTD - where accepted (e.g. some LATAM and Asian regulators are moving to eCTD); requires validated lifecycle
- ACTD - ASEAN format; Parts I-IV largely map to CTD Modules 1-5
- Paper - still accepted by some regulators; volume and indexing requirements
Common Pitfalls #
- Module 1 not localised to target country
- Expired CoPP or GMP certificate at submission
- Stability data not covering the specific pack configuration marketed
- Missing BE data or reference product documentation
- Inconsistent specification between Module 3 and Module 2.3 QOS
Taj Pharma provides full CTD dossier support - see CTD Dossier Availability.